In the 1990s and 2000s, AIDS activists and other global health advocates started pressuring pharmaceutical companies to share their largesse with low- and middle-income countries (LMICs) by supplying critical medicines for free or at subsidized prices, especially for HIV/AIDS. The pressure was successful, and led to a series of access-to-medicine (AtM) initiatives.

The international community increasingly recognizes that the pharmaceutical industry must play a leading role in improving access to medicines. And apparently pharma companies themselves also acknowledge this responsibility, according to a study published in Health Affairs by a team of researchers at Boston University Department of Global Health. That study found that the number of these initiatives grew from 17 in 2000 to 102 in 2015. The researchers called this “clear evidence” that pharmaceutical companies had responded to calls to increase their commitment to improving access to medicines.

The industry’s role was first articulated when the Millennium Development Goals (MDGs) were drafted in 2015. Goal 8, Target 8E read: “In cooperation with pharmaceutical companies, provide access to affordable, essential drugs in developing countries.”

The Sustainability Development Goals, which replaced the MDGs in 2016, further enshrined that idea in Goal 3.8 which aims to “achieve universal health coverage, including financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”

The Health Affairs study identified 385 health initiatives across 21 companies. Of these, 120 were categorized as AtM initiatives. Novartis was first with 14 initiatives, Sanofi was second with 13 and Roche was third with 10 (21 were multi-company partnerships).

The Access to Medicine Foundation, funded by the Bill & Melinda Gates Foundation and the UK and Dutch governments, compiles an index on the progress made by pharma companies to make their medicines accessible. Every two years since 2008, the Foundation has published the Access to Medicine Index. In 2016, Glaxo Smith Kline, Johnson & Johnson and Novartis were named as the leading companies.

The Health Affairs article says the index has created an incentive for expanding AtM initiatives, as well as for more transparent reporting. But it also says that the index’s ranking methodology does not include a rigorous review of the evidence and should be improved to hold companies more accountable.

The Boston University researchers found that few of these initiatives evaluate their activities well. Of the 102 AtM initiatives identified, the researchers found published evaluations for only seven. From those seven, the researchers found 47 articles that met their inclusion criteria but determined that 62 percent of these were low quality, 32 percent were very low quality and 6 percent were moderate quality. None of them were rated high quality.

“Overall, our findings suggest that current efforts to evaluate the impact of industry-led access-to-medicines initiatives are inadequate,” they write.

Boston University is now monitoring and evaluating an AtM initiative in Kenya to address these concerns. The initiative, called Novartis Access, seeks to provide 15 medicines to address breast cancer, cardiovascular disease, type 2 diabetes and respiratory illnesses at a cost of USD $1 per treatment per month. The project started in Kenya in 2015 and plans to expand to 30 countries in coming years. Novartis Access hopes to reach 20 million people per year by 2020.

From the beginning, Novartis Access sought the help of Boston University to evaluate its impact and the prices of these medicines at health facilities and households in Kenya in an objective and transparent manner. Novartis has no control over the evaluation process and Boston University publishes protocols, agreements and all the results on this website.

“One things we know about programs offering low-priced products – not just medicines but also food or fuel – is that it’s often not the poorest people who benefit, but the middle-income groups who know how to access the medicines and appropriate treatment,” said Richard Laing, a professor at Boston University who is involved in the evaluation. “For that reason, we’re very keen to find out what happens at the household level, particularly to the poorest families.”

Laing said this evaluation is different because past efforts to measure the impact of AtM programs have almost always occurred after the fact: “The problem with these evaluations is that you don’t know what the situation was like before, and there is often no control group, so the evaluations have tended to be weak even when the best interventions have take place.”

The Access to Medicine Foundation welcomes additional efforts to evaluate the impact of access to medicine programs, said Danny Edwards, research program manager for the foundation.

“We’ve noticed an increasing orientation of companies in this direction over recent years, from University College London’s independent evaluation of Novo Nordisk’s Base of the Pyramid Program, to Novartis Access, to the explicit commitment of companies participating in Access Accelerated to evaluate and share the impact of the work taking place under that umbrella, which includes Boston University, Union of International Cancer Control and the World Bank.”